POTENZA

The POTENZA is an RF (radiofrequency) electrosurgical device intended for use in dermatologic and general surgical procedures to coagulate soft tissue and achieve hemostasis. It generates RF energy at 1 MHz or 2 MHz delivered through a handpiece with electrode tips to create controlled thermal injury in target tissue.

The subject device is identical to the predicate POTENZA (K201685) except for the addition of three new electrode tips (CP-16, CP-25, CP-49) for the motor handpiece. These new tips have slightly different physical dimensions and needle thickness compared to the predicate's I-series tips, but operate on the same monopolar/bipolar RF principles with the same 50W maximum power and 1-2 MHz frequency range.

Biocompatibility testing per ISO 10993 parts 5, 10, 11, 23, and part 4 (hemolysis); electrical safety and EMC per IEC 60601-2-2:2017 and IEC 60601-1-2:2014; ex vivo thermal testing on liver, kidney, and muscle tissue per FDA's August 2014 Guidance for Electrosurgical Devices.

The new CP-series electrode tips are technically similar to the predicate I-series tips in terms of treatment area dimensions and inter-needle spacing for the CP-49 and CP-25 variants. Performance testing confirmed the added tips do not raise new or different safety or effectiveness questions. Since the handpiece, main unit, operating modes, power output, and frequency are unchanged from the predicate, and the new tips are minor variations on existing electrode designs with comparable biocompatibility and thermal performance characteristics, substantial equivalence is established.